The purpose of this study is to assess the safety and performance of the ECHELON 3000 Stapler (next generation powered stapler) and reload system in participants undergoing laparoscopic sleeve gastrectomy or lung resection procedures (Video-Assisted Thoracoscopic \[ATS\] or open approach).
Study Type
OBSERVATIONAL
Enrollment
244
There is no intervention, beyond necessary clinical care, in this study. Echelon 3000 Stapler is used for transection and resection in LSG or lung surgical procedure per its IFU.
Cedars-Sinai Medical Center
Los Angeles, California, United States
George Washington University Hospital
Washington D.C., District of Columbia, United States
Emory Cardiothoracic Surgery
Atlanta, Georgia, United States
Henry Ford Health Center
Detroit, Michigan, United States
Number of Participants with Select Device-related Serious Adverse Events (SAEs)
An adverse event (AE) is defined as any untoward medical occurrence, regardless of its relationship to study device or study procedure. An untoward medical occurrence includes any new, undesirable medical experience or worsening of pre-existing condition, which occurs throughout the duration of the clinical study. SAE is defined as an AE that results in any of the following: death; a life-threatening illness or injury; a permanent impairment of a body structure or body function; hospitalization or prolongation of existing hospitalization; medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or body function; chronic disease; fetal distress, fetal death, or a congenital physical or mental impairment or birth defect. The device-related SAEs that will be captured are infection or symptoms of infection, bleeding, gastric leak (laparoscopic sleeve gastrectomy \[LSG\] only), and postoperative air leak (lung resection only).
Time frame: 30 days post procedure
Number of Participants with All Device-related, Procedure-related Adverse Events (AEs)
An AE is defined as any untoward medical occurrence, regardless of its relationship to the study device or the study procedure. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs throughout the duration of the clinical study.
Time frame: 30 days post-procedure
Number of Participants with All Device-related, Procedure-related SAEs
An AE is defined as any untoward medical occurrence, regardless of its relationship to the study device or the study procedure. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs throughout the duration of the clinical study. A SAE is defined as an AE that results in any of the following: death; a life-threatening illness or injury; a permanent impairment of a body structure or a body function; hospitalization or prolongation of existing hospitalization; medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function; chronic disease; fetal distress, fetal death, or a congenital physical or mental impairment or birth defect.
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Ascension Providence Hospital
Southfield, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Bariatric Medical Institute of Texas
San Antonio, Texas, United States
Time frame: 30 days post-procedure